Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

问题：颈椎损伤（CSI）是严重的，但在儿童中很少见。相反，使用脊柱 在急诊科（艾德）进行CSI的创伤转运和影像学评价的注意事项是 常见且与不良反应相关。结果，数百万没有CSI的儿童暴露在 没有明显好处的伤害。国家的EMS系统需要儿科CSI风险评估工具 这可以用来减少在脊柱预防措施和辐射中运送的儿童数量， 不必要的。伦纳德等人和儿科急救应用研究网络（PECARN） 回顾性地确定了8个预测儿童CSI的危险因素。我们还建立了基础设施， 前瞻性地从EMS和艾德供应商处收集配对观察结果，并确定 PECARN CSI风险因素。目标：我们建议开发和测试儿科CSI风险评估工具 EMS和艾德提供者可以使用这些信息来确定哪些儿童需要脊柱预防措施， 颈椎钝伤后影像学检查具体目标：使用前瞻性观察数据， 来自认知任务分析（ACTA）的信息，由主题专家和相关终端进行， 用户，我们将使用以用户为中心的设计方法1）开发儿科CSI风险评估工具， 钝伤儿童和2）在一个单独的人群中使用儿科CSI风险评估工具， 钝伤儿童; 3）使用EMS观察结果评估儿科CSI风险评估工具 从开发和验证队列中。协调：我们将在15 PECARN进行这项工作 创伤中心方法：我们将从EMS和艾德提供者处收集前瞻性观察数据 关于儿童在钝伤后接受紧急评估并随访的CSI风险因素， 入组受试者28天，以确定CSI状态。研究将分两个阶段进行： (13，333名儿童; 240名CSI儿童）和验证（8，889名儿童; 160名CSI儿童）。我们还将 利用研究基础设施进行ACTA和工具原型测试， 迭代工具设计，以确保EMS和艾德提供商可以使用该工具。评价：数据来自 开发队列，将构建一个可用的临床决策支持工具，实现>95% 在预测CSI方面具有足够的敏感性和特异性（>40%）。随后，我们将确定 独立确认队列和具有EMS的队列中工具的性能特征 供应商观察该项目的最终输出将是一套儿科CSI规范 风险评估工具，包括经确认的临床决策规则、经确认的工具设计和功能， 和执行建议。意义：一个准确的，经过验证的，并最终经过现场测试的 儿科CSI风险评估工具将安全地限制不必要的脊柱预防措施和放射学检查 为数百万儿童提供服务，同时帮助确定那些真正有可能患上CSI的儿童。

Problem: Cervical spine injuries (CSI) are serious, but rare events in children. In contrast, use of spinal precautions for trauma transport and radiographic evaluation for CSI in the emergency department (ED) are common and associated with adverse effects. As a result, millions of children who have no CSI are exposed to harm with no demonstrable benefit. The nation’s EMS systems need a Pediatric CSI Risk Assessment Tool that can be used to reduce the number of children who are transported in spinal precautions and irradiated unnecessarily. Leonard et al. and the Pediatric Emergency Care Applied Research Network (PECARN) retrospectively identified 8 risk factors that predict CSI in children. We also established the infrastructure to prospectively collect paired observations from EMS and ED providers and determined the test accuracies of the PECARN CSI risk factors. Goal: We propose to develop and test a Pediatric CSI Risk Assessment Tool that can be used by EMS and ED providers to determine which children warrant spinal precautions and cervical spine imaging after blunt trauma. Specific Aims: Using prospective observational data and information from a cognitive task analysis (ACTA) conducted with subject matter experts and relevant end- users, we will use a user-centered design approach to 1) Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma and 2) Validate the Pediatric CSI Risk Assessment Tool in a separate population of children with blunt trauma; and 3) Validate the Pediatric CSI Risk Assessment Tool with EMS observations from both the development and validation cohorts. Coordination: We will conduct this work at 15 PECARN trauma centers. Methodology: We will collect prospective observational data from EMS and ED providers regarding CSI risk factors for children who undergo emergency evaluation after blunt trauma and follow enrolled subjects for 28 days to determine CSI status. The study will occur in two phases: development (13,333 children; 240 children with CSI) and validation (8,889 children; 160 children with CSI). We will also capitalize on the research infrastructure to conduct an ACTA and tool prototype testing that will inform the iterative tool design to ensure that the tool is useable by EMS and ED providers. Evaluation: With data from the development cohort, a useable clinical decision support tool will be constructed that achieves >95% sensitivity, as well as adequate specificity (>40%) in the prediction of CSI. Subsequently, we will determine the performance characteristics of the tool in the independent validation cohort and in a cohort that has EMS provider observations. The ultimate output from this project will be a set of specifications for the Pediatric CSI Risk Assessment Tool that will include a validated clinical decision rule, validated tool designs and functions, and recommendations for implementation. Significance: An accurate, validated, and ultimately field-tested Pediatric CSI Risk Assessment Tool will safely limit unnecessary spinal precautions and radiographic testing for millions of children while helping identify those children who are truly at risk for CSI.